IRB Applications and Forms
The applications and forms shown below are updated on a regular basis. Please download a new copy each time you use them to ensure you are using the most current version. Also note that many of the forms/application have both a Behavioral/Social Sciences version and a Health Sciences version. Please make sure that you are using the correct type. Forms are available for download in MS Word (PC) and Rich Text Format (MAC) by clicking the "W" or "Apple" icons.
The SMOG Readability Tool is a recommended and tested method for determining the readability level of written materials.
Behavioral/Social Science Forms and Applications
| Behavioral/Social Sciences Application (Form #1124) |  |
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| Behavioral/Social Sciences Expedited Application (Form #1119) | |
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| Instructions - Behavioral/Social Sciences Standard and Expedited Application | |
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| NEW 5/1/2012 |
Behavioral/Social Sciences Continuing Review Application (Form #1129) | |
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| Instructions - Behavioral/Social Sciences Continuing Review Application | |
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| Exemption Request (Form #1102) | |
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| Instructions - Exemption Request Form | |
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| Specimen/Data Repository Application (Form #1103) | |
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| Instructions - Specimen/Data Repository Application | |
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| Specimen/Data Continuing Review Application (Form #1137) | |
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| Umbrella Request (Form #1106) | |
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| Instructions - Umbrella Request | |
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| Umbrella Continuing Review Application (Form #1113) | |
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| Instructions - Umbrella Continuing Review Application | |
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Health Science Forms and Applications
| NEW 4/27/2012 |
Health Sciences Application (Form #1100) | |
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| NEW 4/27/2012 |
Health Sciences Expedited Application (Form #1133) | |
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| Instructions - Health Sciences Standard and Expedited Application | |
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| NEW 5/1/2012 |
Health Sciences Continuing Review Application (Form #1101) | |
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| Instructions - Health Sciences Continuing Review Application | |
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| Coordinating Center Application (Form #1125) | |
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| Exemption Request (Form #1102) | |
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| Instructions - Exemption Request Form | |
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| Specimen/Data Repository Application (Form #1103) | |
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| Instructions - Specimen/Data Repository Application | |
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| Specimen/Data Continuing Review Application (Form #1137) | |
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| Umbrella Request (Form #1106) | |
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| Instructions - Umbrella Request | |
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| Umbrella Continuing Review Application (Form #1113) | |
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| Instructions - Umbrella Continuing Review Application | |
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HSRC/RDRC Applications
| FDA Form 2915 | |
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| Human Subjects Radiation (HSRC) Application (Form #1107) | |
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| Instructions - Human Subjects Radiation (HSRC) Application | |
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| Radioactive Drug Research (RDRC) Application (Form #1108) | |
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| Instructions - Radioactive Drug Research (RDRC) Application | |
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| Radiation Dose Calculator |
Supplemental Forms
| Coded Data Agreement (Form #1142) | |
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| Coordinating Center Supplemental Form (Form #1132) | |
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| Department Chair/Division Chief Signature Form | |
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| Research Procedure Supplemental Form (Form #1140) | |
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| Phase I and Phase I/II Supplemental Form (Form #1143) | |
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| Instructions - Phase I and Phase I/II Supplemental Form | |
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| Specimen/Data Repository Supplemental Form (Form #1136) | |
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| Supplemental Form for Devices (Form #1134) | |
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| Instructions - Supplemental Form for Devices | |
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| Investigator Held IND Supplemental Form (Form #1135) | |
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| Vulnerable Population Form - Children (Form #1117) | |
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| Instructions - Vulnerable Population (Children) | |
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| Vulnerable Population Form - Cognitively Impaired (Form #1118) | |
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| Instructions - Vulnerable Population Form (Cognitively Impaired) | |
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| Vulnerable Population Form - Pregnant Women/Fetus/Neonate/Fetal Material (Form #1116) | |
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| Instructions - Vulnerable Population Form (Pregnant Women/Fetus/Neonate/Fetal Material) | |
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| Vulnerable Population Form - Prisoners (Form #1115) | |
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| Instructions - Vulnerable Population Form (Prisoners) | |
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Informed Consent and Assent Documents
| Assent Document | |
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| Behavioral/Social Sciences - Standard Informed Consent Document | |
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| Health Sciences - Standard Informed Consent Document | |
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| Instructions - Informed Consent and Assent | |
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| Informed Consent Document - Short Form | |
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| Informed Consent Document - Spanish Short Form | |
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| Instructions - Short Form | |
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| Informed Consent Document - Emergency Use | |
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| Bio/Data Repository Rider for Informed Consent Documents | |
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| Genetic Screening Rider for Informed Consent Documents | |
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| Surrogate Rider for Informed Consent Documents | |
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| Translator Declaration Statement | |
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| Waiver of Consent and/or Authorization to Access PHI (Form #1112) | |
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| Instructions - Waiver of Consent and/or Authorization to Access PHI | |
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Additional Forms
| Adverse Event Reporting Flowchart | |
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| Complaint Report (Form #1114) | |
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| Confidentiality Agreement | |
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| Conflict of Interest Opinion Request (Form #1120) | |
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| Conflict of Interest Decision Tree | |
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| Data Use Agreement (Form #1109) | |
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| FDA Form 1571 - Investigational New Drug Application (IND) | |
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| FDA Form 1572 - Statement of Investigator | |
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| FDA Form 2891 - Investigational New Device (IDE) (submit in triplicate) | |
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| Non-Human/Non-Research Determination Request (Form #1122) | |
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| Instructions - Non-Human/Non-Research Determination | |
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| MOU Site Checklist | |
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Retired Forms
| RETIRED | Adverse Event Report (Form #1105) (available electronically within DISCOVR-E) | |
| RETIRED | Notification of Non-compliance with the Protocol (Form #1123) (available electronically within DISCOVR-E) | |
| RETIRED | Instructions - Notification of Non-compliance with the Protocol | |